A5074280458- Ethics in Clinical Research
- Health Systems, Economic Evaluations, Quality of Life
- Palliative Care and End-of-Life Issues
- Biomedical Ethics and Regulation
- Patient Dignity and Privacy
- Ethics in medical practice
- Healthcare cost, quality, practices
- Pharmaceutical industry and healthcare
- Patient-Provider Communication in Healthcare
- Meta-analysis and systematic reviews
- Statistical Methods in Clinical Trials
- Childhood Cancer Survivors' Quality of Life
- Ethics and Legal Issues in Pediatric Healthcare
- Artificial Intelligence in Healthcare and Education
- EEG and Brain-Computer Interfaces
- Grief, Bereavement, and Mental Health
- Pharmaceutical Economics and Policy
- Pharmacovigilance and Adverse Drug Reactions
- Mental Health and Psychiatry
- Psychology of Moral and Emotional Judgment
- Healthcare Decision-Making and Restraints
- Medical Coding and Health Information
- Economic and Financial Impacts of Cancer
- Health Policy Implementation Science
- Optimism, Hope, and Well-being
University Medical Center Utrecht
2016-2025
Utrecht University
2011-2025
Cal Humanities
2015-2023
Leidsche Rijn Julius Health Centers
2023
University Hospital Heidelberg
2015-2022
Heidelberg University
2015-2022
Geneeskundige en Gezondheidsdienst
2022
Stichting Epilepsie Instellingen Nederland
2018
Kempenhaeghe
2018
Eindhoven University of Technology
2018
<h2>Abstract</h2> This is the introductory paper in a series of eight papers. In this series, we integrate theoretical design options with practice conducting pragmatic trials. For most new market-approved treatments, clinical evidence insufficient to fully guide physicians and policy makers choosing optimal treatment for their patients. Pragmatic trials can fill gap, by providing on relative effectiveness strategy routine practice, already an early phase development, while maintaining...
Background: The practice of euthanasia and physician-assisted suicide (PAS) in the Netherlands has been regulated since 2002 by Euthanasia Act. In ongoing debate about interpretation this Act, comparative information opinions different stakeholders is needed. Aim: To evaluate Dutch physicians, nurses general public on legal requirements for PAS. Design: A cross-sectional survey among physicians primary secondary care members public, followed qualitative interviews selected respondents....
<h3>Objective</h3> To develop and prospectively evaluate a method of epileptic seizure detection combining heart rate movement. <h3>Methods</h3> In this multicenter, in-home, prospective, video-controlled cohort study, nocturnal seizures were detected by (photoplethysmography) or movement (3-D accelerometry) in persons with epilepsy intellectual disability. Participants >1 monthly major wore bracelet (Nightwatch) on the upper arm at night for 2 to 3 months. Major tonic-clonic, generalized...
Decentralized clinical trials (DCTs) have the potential to improve accessibility, diversity, and retention in by moving trial activities participants' homes local surroundings. In this study, we conducted semi-structured interviews with 20 European regulators identify regulatory challenges opportunities for implementation of DCTs Union. The key that were recognized include a reduced participation burden, which could facilitate underserved patients. addition, indicated data collected are...
Research ethics committees (RECs) evaluate whether the risk-benefit ratio of a study is acceptable. Decentralized clinical trials (DCTs) are novel approach for conducting that potentially bring important benefits research, including several collateral benefits. The position in assessments currently unclear. DCTs raise therefore questions about how these should be assessed. This paper aims to reconsider different types research benefits, and their assessments. We first propose categorization...
Background The Dutch euthanasia law regulates physician assistance in dying for patients who are suffering unbearably from a medical condition. We studied the attitudes of population to older persons have wish die without presence serious Methods A cross-sectional survey was conducted among random sample public (response rate 78%, n=1960), using statements and vignettes about tired living. Results minority 26% agreed with vignette which warrants request physician-assisted suicide an person...
Big data is central to new developments in global clinical science aiming improve the lives of patients. Technological advances have led routine use structured electronic healthcare records with potential address key gaps evidence. The covid-19 pandemic has demonstrated big and related analytics, but also important pitfalls. Verification, validation, privacy, as well social mandate undertake research are challenges. European Society Cardiology BigData@Heart consortium brought together a...
In 2015, euthanasia accounted for 4.5% of deaths in the Netherlands, which 93% were performed by a GP. Historically, conflict physician's duties-to alleviate unbearable suffering and at same time preserve patient's life-is central to justification practice Netherlands. However, there seems be shift towards greater emphasis on autonomous wish as primary basis euthanasia. This has consequences role interpretation duties end-of-life care. paper aims describe these developments decision-making....
The Dutch law states that a physician may perform euthanasia according to written advance directive (AED) when patient is incompetent as long all legal criteria of due care are met. This also hold for patients with advanced dementia. We investigated the differing opinions physicians and members general public on acceptability in In this qualitative study, 16 medical specialists, 19 practitioners, elderly were interviewed asked their about vignette based an AED Members perceived dementia...
Automated seizure detection and alarming could improve quality of life potentially prevent sudden, unexpected death in patients with severe epilepsy. As currently available systems focus on tonic-clonic seizures, we want to detect a broader range types, including tonic, hypermotor, clusters seizures.In this multicenter, prospective cohort study, the nonelectroencephalographic (non-EEG) signals heart rate accelerometry were measured during night undergoing diagnostic video-EEG examination....
Decentralized clinical trials (DCTs) can be a valuable addition to the trial landscape. However, practice of DCTs is dependent on regulatory system designed for conventional (site-based) trials. This study provides insight into ethics review DCTs. A 'mock review' was performed in which members European committees (ECs) and national competent authorities (NCAs) discussed reviewed DCT protocol. Respondents expressed hesitancy toward focused potential risks burdens. We advise address these...
Pragmatic trials may deliver real-world evidence on the added value of new medications compared with usual care and inform decision making earlier in development. This fifth paper a series pragmatic Journal discusses as comparator allocation treatment strategies. The implementation strategies should resemble clinical practice closely possible. Randomization at level site, opposed to individual level, be preferred. Data analysis according intention-to-treat principle is recommended, crossover...
The Dutch Regional Euthanasia Review Committees (RTEs) reviewed and reported an increasing number of cases euthanasia physician-assisted suicide (EAS) requested by older people with multiple geriatric syndromes (MGS). Knowledge the characteristics EAS for MGS is important to facilitate societal debate monitor practice.To examine accumulation patient characteristics, syndromes, other circumstances as in case summaries RTEs that led unbearable suffering associated a request analyze RTEs'...